MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR

Model Number 96102

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/20/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report from the customer that a patient injury occurred on (b)(6) 2021.

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report from the customer that a patient injury occurred on (b)(6) 2021.

Manufacturer Narrative

A spacelabs healthcare technical support representative (tsr) retrieved device logs from the biomedical engineer.A spacelabs healthcare product support specialist (pss) evaluated the event log from the customer¿s xhibit central station, and it was confirmed that the alarms were manually disabled at the station by the end user.As a precaution, a spacelabs healthcare field service engineer (fse) went to the customer¿s location to evaluate their xhibit central station.It was confirmed that visual and audible alarms were working as expected and the station was returned to service after proper device operation was observed through functional and performance testing.No fault was found with the device at the time of the event.This report is complete, and the issue is considered closed.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 12981285
• MDR Text Key: 285468860
• Report Number: 3010157426-2021-00071
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96102
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 03/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 41 KG